Method of controlling the release of carbohydrates by encapsulation and composition therefor

ABSTRACT

A composition of carbohydrates having an edible coating is disclosed, whereby the coated carbohydrate, when orally ingested, causes a time delay release of the carbohydrate into the digestive system. The method of administering carbohydrates in this manner may be useful in the treatment of diseases such as diabetes and exercise programs calling for sustained effort.

BACKGROUND OF THE INVENTION

The present invention relates to a method for preparing a delayedrelease encapsulated carbohydrate composition in solid particulate formfor use in snacks, candy, dessert mixes, granola bars, energy bars,various beverages, and shelf stable powders.

In the preparation of various foodstuffs and other ingested items, suchas vitamins, drugs and the like, such foodstuffs having beenencapsulated to provide a delayed release flavor, medicinal action orthe like. As stated above, the subject invention relates to anencapsulated and coated metabolizable carbohydrate composition which hasa controlled release upon ingestion whereby the carbohydrates are slowlyreleased into the body's digestive tract. This delayed release actioncan be very helpful in counteracting the effects of diseases, such asdiabetes which is characterized by a raised glucose concentration in theblood due to a deficiency or diminished effectiveness of insulin. Thedisease is chronic and also affects the metabolism of fat and protein.In general, some cases can be controlled by diet alone while othersrequire diet and insulin, and for still others control with drugs isneeded.

When controlling the effects of diabetes with diet, the diabetic isadvised to control the timing of meals and snacks, control thecomposition of the food, and monitor the caloric content of the food.The diabetic who eats a high-calorie, high-carbohydrate meal willexperience elevated blood glucose levels one-half to one hour afteringestion. To minimize this effect, a physician normally counsels hispatient to distribute the carbohydrate load over several spaced snacksand meal occasions. A non-diabetic person could eat a highcarbohydrate/caloric meal and the carefully modulated insulin responseof his body will maintain the blood glucose levels within normal rangesof 70-120 mg/dl. A diabetic who has impaired insulin metabolic controlshas to rely on external control mechanisms, i.e., the timing of meals,the composition of the meals, and the caloric density of the meals. Forthe more severe cases of diabetes, drugs have been developed whichmodulate the blood glucose response by interfering with the enzymeswhich break down starch or sugar in the upper G.I. tract. The effect isto prolong the digestion and absorption of glucose as food traverses theG.I. tract.

Other reasons exist for modulating the blood glucose response, such asthe demands of exercise, nutrition and the like.

SUMMARY OF THE INVENTION

Therefore, an object of the subject invention is an encapsulatedcarbohydrate composition which causes a timed delay release of thecarbohydrates in the digestive tract of the human body.

Another object of the subject invention is a shelf-stable powder capableof being stabilized and suspended in a liquid medium for easierdispersion and a timed release into the digestive tract of the humanbody.

A further object of the subject invention is a method of encapsulatingmetabolizable carbohydrates as a time-delay mechanism for ingestion anddigestion by a subject in a controlled manner.

These and other objects are obtained by the subject invention whereinthe release of carbohydrates to the absorption sites in a G.I. tract ofa human is controlled by encapsulating the desired metabolizablecarbohydrates (starch, glucose, sucrose, fructose, etc.) in a food orpharmaceutical grade coating. As the encapsulated particle moves downthe digestive tract, the coating degrades and slowly releases thecarbohydrate. Thus, by coating the food particle, absorption in theupper G.I. tract could be experienced over a one-half to four-hour timeperiod which would help modulate the blood glucose levels and possiblyeliminate or reduce the need for a diabetic to snack between meals.

In the method of the subject invention, the carbohydrate may bespray-coated in a coating pan or in a fluidized bed, or coated directlyon a rotating disc, all in a manner which provides a substantially equaldistribution of the coating on the carbohydrate. Both liquid and solidcarbohydrates may be coated by use of appropriate coating techniques.The coated particle is then administered.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a graph showing the percent glucose released as a function oftime.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the method of the subject invention, metabolizable carbohydrates suchas sucrose, glucose, lactose, dextrins, pre-gelatinized starches,fructose, maltose and other mono, di, oligo, and polysaccharides whichare normally absorbed and metabolized in the digestive tract may becoated with a food or pharmaceutical grade coating such as stearic acid,hydrogenated or partially hydrogenated oils, such as cottonseed, soybeanor rape seed oil, calcium stearate, stearyl alcohol and the like. Thecoating may be from any of various processes, including coating in acoating pan, spraying, fluidized bed, or utilizing the rotating discmethod such as disclosed in U.S. Pat. Nos. 5,100,592 and 4,675,140.

In the method of the subject invention, the carbohydrate core is coatedso as to experience controlled, delayed absorption when ingested intothe human body. The coated product should result in a shelf-stablepowder with particle size range of 30 to 1,000 μm. The actual size ofthe particle would depend both on dissolution rates desired andorganoleptic characteristics of the food system in which it isadministered. In general, where a smoother textured food is required,such as beverages, a finer particle size range (75-150 μm) would beutilized. For food systems where the food is masticated, larger sizedparticles could be used (+150 μm). Because the active component isencapsulated by the method of the subject invention, the resultingcoated particles would be relatively inert and bland in both aroma andtaste. This would allow the coated particle of the subject invention tobe incorporated in a variety of foods without affecting thecharacteristic properties and flavors of the food.

The coating set forth above could be selected to be compatible with thecomponents and preparation of the food. For instance, ethyl cellulose, anon-food ingredient, could be selected for foods containing free fats oroils and elevated preparation temperatures of up to 100° C. Hydrogenatedtallow and stearic acid coatings would be suitable where temperatures donot exceed 60° C. and significant quantities of free lipids are notpresent.

In the following example, several methods of coating carbohydrates areset forth where the in vitro release rates of some of the products whichhave been obtained by such coating, are shown.

EXAMPLE 1 Coating of Glucose with Stearic Acid in a Coating Pan

D-glucose was sieved to obtain 250 g of a fraction which passed througha 300 μm sieve but was retained by a 177 μm sieve. This was placed intothe coating pan such as is commonly used in the pharmaceutical industryto coat tablets. In order to have a sufficient amount of material in thepan for proper mixing and coating, it was found necessary to add anothersolid which was of a larger size so that after coating, it could beseparated from the glucose. Approximately 500 g table salt of about 420to 500 μm was used for this purpose. Stearic acid, 375 g, was dissolvedin 1875 ml of hot (75° C.) ethanol.

The pan was set to rotate 50 to 55 RPM. A two-fluid nozzle was connectedto a hot air supply which was regulated between 15 to 22 psi. Theethanol solution was supplied to the liquid side of the nozzle at a rateof about 10 ml/min. Room temperature air was blown into the pan to helpevaporate the ethanol. Samples were removed from the pan after 20, 30,40 and 50 parts of stearic acid had been sprayed per 100 parts of solidsbeing coated in the pan.

After 50 parts were sprayed, the solids were separated by sieving. Thefraction 75 to 420 μm was tested except for the highest level of coatingwhere the fraction of 180 to 300 μm was also tested. To test therelease, 2 g of the coated sample was shaken in 100 ml of water in a 250ml plastic bottle (approximately 1 inch travel 60 cycles/min).Periodically, approximately 3 ml of the solution was withdrawn and theconcentration determined by measuring the refractive index of thesolution relative to that of pure water (differential refractive index).After the measurement, the solution was returned to the bottle. After 1day, the particles were filtered out of the solution and crushed with amortar and pestle. The crushed particles were combined with the solutionand concentration was measured again. This represents the concentrationcorresponding to 100% of the glucose released. To obtain the percentglucose release, the glucose concentration in the solution at any timewas divided by the concentration corresponding to 100% released. Theloading was calculated by dividing the concentration corresponding tothe 100% of the glucose released by the concentration corresponding to 2g uncoated glucose in 100 ml.

FIG. 1 shows the percentage of glucose released from the particles ofExample 1 versus time. It may be seen that when the amount of coatingincreases, the rate of release is decreased. And that the time scale maybe adjusted to release the glucose in a time corresponding to theresidence time in the gastro-intestinal tract by suitable adjustments inthe process.

EXAMPLE 2 Coating on a Rotating Disc With Solutions of Polymers

The rotating disc allows rapid coating of particles. Approximately 100 gglucose passing a 125 μm sieve but being retained by a 75 μm sieve wereslurried into 200 ml solution of acetone 4 parts to 1 part of ethanolcontaining 7.5% w/v ethyl cellulose and immediately poured into thecentral opening of a rotating vaned disc (8 inches in diameter with 24vanes) rotating at 10,000 RPM. The particles were dry and wereimmediately collected. When tested for release, the 75 to 300 μmfraction which had a payload of 89% (11% coating) corresponding to anaverage wall thickness of 9.6 μm released 82% of its glucoseconcentration in 5 minutes and 97% in 20 minutes. This coating thusshows only slight protection and would not be sufficient on its own butmay serve as a prime coat. A second coat is a hot melt coat containingtristearin, which is applied by spraying from solution. Other fats andfat-like substances, including triglycerides such as tristearin,tripalmitin, trilaurin or glyceryl behenate or mixtures thereof,diglycerides and monoglycerides as well as free paraffin wax, bees wax,carnauba wax, and microcrystalline waxes allowed as part of food or drugcomponents. Proteins may also be utilized as a second coating and may beegg albumin, casein, zein, or soy proteins. Semi-synthetic polymers mayalso be used and include ethyl cellulose, cellulose acetate phthalate,hydroxypropyl methyl cellulose phthalate. Synthetic polymers also arepossible for use as a second coating and include acrylate copolymersapproved for coating of medical forms for oral ingestion. Application ofthese materials may generally be accomplished by spraying from solution,dispersion or emulsion, as appropriate.

EXAMPLE 3 Coating on the Rotating Disc With an Edible Hot Melt

A hot melt was prepared as follows: 26 g stearic acid was melted andheated to 150° C. 10.5 g ethyl cellulose (7 cps) was dissolved in it.103 g hydrogenated tallow was added and the liquid brought to about 85°C. 70 g of the product from Example 2 passing a 150 μm sieve but beingretained by a 75 μm sieve was added to the melt and stirred in to make ahomogeneous mixture. The rotating disc used in Example 2 was heated to80° C. and turned on to rotate at 10,000 RPM and the slurry poured intothe opening of the disc at the rate of about 300 ml/min. Two fractionswhich represented together 83% of the product were tested 75 to 150 μmand 150 to 300 μm. The payload was 34 and 44% respectively. In 5minutes, the release rate was 51.4 and 20.5%, in 20 minutes 61.2 and34.7% was released, in 80 minutes, 74.3 and 65.6% was released. After 5hours, 81% of both fractions were released.

EXAMPLE 4 Coating of Glucose in a Fluidized Bed With a Solution of EthylCellulose

750 g anhydrous glucose, passing a 300 μm screen but being retained by a177 μm screen was placed in a fluidized bed (6 inch diameter) where itwas fluidized with air from below. Ethyl cellulose was dissolved inacetone ethanol 4/1 by volume to make a 3% w/v solution. The solutionwas sprayed with a two-fluid nozzle using air at an air pressure of 25psi and a liquid rate of about 8 ml/min. It was sprayed on until 5.4% ofcoating was deposited. The 75 to 300 μm fraction was tested. 46.8% wasreleased in 5 minutes, 72.6% was released in 20 minutes, 91% wasreleased in 80 minutes.

EXAMPLE 5 Coating of Fructose in a Coating Pan with Stearic Acid

Fructose was sieved to remove particles smaller than 420 μm. 650 g ofthis was placed in the apparatus described in Example 1 and coated withstearic acid by spraying a 20% w/v solution in ethanol as in Example 1.A sample removed from the run had a payload or glucose content of 75.9%.In the standard release test, it released 45.1% in 10 minutes, 48.2% in1 hour, 64% in 3 hours, 91% in 19 hours.

EXAMPLE 6 Coating Corn Starch With Hydrogenated Tallow on the RotatingDisc

40 g stearic acid (Witco Hystrene 9718) was melted and heated to 135° C.20 g ethyl cellulose (Dow, Ethocel of 7) was dissolved in it. Then 140 gof hydrogenated tallow (Kraft) was added and dissolved. 100 g cornstarch Mira-Gel 463 (Staley) was dispersed in the melt and sprayed withan 8-inch diameter vaned disc at 10,000 RPM. 245 g of product wascollected.

The particles of product ranged from about 30 to 300 μm in size. Theoriginal starch granules are about 15 μm; therefore, several of thegranules make up a product particle glued together by the hot melt.

To determine the active content, the product was ground with a mortarand pestle and 1 g placed into cellophane tubing with a 6000 molecularcut-off. Also into the tube was placed 30 ml water 0.05 ml BAN 120Lamylase, 6 units (Novo Nordisk) and 2 ml AGM 200 L amyloglucosidase 400units (Novo Nordisk). 1 unit of amylase breaks down 5.25 g of solublestarch per hour at 37° C. and pH 5.6. 1 unit of amyloglucosidaseshydrolyses 1 micromole of maltose per minute at 25° C. and pH 4.3. Theends of the cellophane were tied, and formed into a U-shape and immersedinto 300 ml of acetate buffer of pH 4.5. The buffer was stirred with amagnetic stirrer and thermostatted at 37° C. 5 ml samples were takenfrom the buffer after 12, 24, and 48 hours, frozen and analyzed with theHitachi 747 glucose hexokinase method. A calibration with glucose in thepresence of the enzyme is necessary. The amount of glucose liberatedfrom this sample was 49% of that of the uncoated Mira-Gel and did notchange appreciably after 12 hours.

To determine the rate of available glucose in a simple simulateddigestion, we proceeded as above, except 821 mg of unground productcontaining 403 mg of starch was used. The buffer was sampled at 20minutes, 1 hour, 4 hours and 8 hours after the start of the experiment.The samples were frozen and later analyzed. The coated Mira-Gel starchshowed the following release:

    ______________________________________                                        Time          Coated Starch                                                   ______________________________________                                        20 minutes    14%                                                             1 hour        32%                                                             4 hours       72%                                                             ______________________________________                                    

Controlled release of carbohydrates from pre-gelatinized starch granulesobtained from other starchy foods would also be achievable by the aboveencapsulation methods. This would include starches obtained fromcereals, such as wheat and rice, and froth starches obtained from rootcrops, such as potato and tapioca.

Diabetes patients who are taking insulin or oral hypoglycemic drugs areprone to low blood sugar reactions especially during or after exerciseor increased activity. Low blood sugar or hypoglycemia is defined as ablood glucose level below 50 mg/dl and is potentially a very serious,acute complication of diabetes. A normal blood sugar range is generally70 to 120 mg/dl. Symptoms of hypoglycemia range from shakiness,light-headedness and tachycardia to headache, blurred vision, poorcoordination and eventually to loss of consciousness and death. Thereare two main counter-regulatory hormones that help the body recover fromhypoglycemia: glucagon and epinephrine. Decreased hormone secretion inpeople who have had diabetes for several years can cause more frequentlow blood sugar reactions and more difficulty in noticing that bloodsugar is low.

To exercise safely, diabetics often have to increase food intake eitherbefore, during or after exercise. Exercise of moderate intensity(doubles tennis, leisurely biking, golfing) requires about 10 to 15grams of carbohydrates per hour of exercise. One to two hours ofstrenuous activity may require 25 to 50 grams of additionalcarbohydrates. A beverage or snack bar with controlled releasecarbohydrates lends itself to preventing low blood sugar during andafter exercise.

Controlled release carbohydrates (CRC) may be described as ashelf-stable powder with a particle size range of 30-1000 μm. Productsin which a smooth, non-gritty texture was desired would utilize thefiner particle size range. Products which are granular or have largeparticles could utilize the larger particle size range.

When the active components are encapsulated according to the subjectinvention, CRC powders are relatively inert and bland in both aroma andtaste. This will allow CRC to be incorporated in a variety of foodswithout affecting the characteristic properties and flavor of food.Alternatively, colorants and flavors can be added to coatings to improveconsumer acceptance. Emulsifiers can be incorporated as part of coatingto aid in dispersion in the food system.

CRC powders in which the coated carbohydrate is readily water solublereleases its load by a diffusion process as it transits the digestivesystem. Therefore, these products would have to be prepared by mixing ina liquid system or a viscous food system, e.g., yogurt, and consumed5-15 minutes after preparation.

CRC powders may be prepared in which the coated carbohydrate is apre-gelatinized starch. The carbohydrate load would be released byhydration, swelling and reaction with the digestive amylases. Hence, CRCpowders based on starch granules would have extended stability in liquidsystems. This would extend the food application to RTE foods (puddings,yogurts, frozen novelties) and ready to drink beverages.

CRC powders could be added to food products which are low in wateractivity-dry beverages, nutritional beverage powders, dessert mixes.Product would be prepared according to recipe and consumed.

CRC powders could be used as a sole source of carbohydrates in the foodor in combination with uncoated rapidly absorbed carbohydrates.

CRC powders are designed to release the bulk of their carbohydratepayload within approximately four hours after ingesting. Release timessignificantly longer than four hours would incur the release ofexcessive carbohydrates in to the large intestine. This would affect theosmotic water balance and increase the risk of bacterial fermentationleading to increased gas formation and laxation.

Calculation of Caloric Delivery for CRC Materials

CRC products are produced by coating glucose granules with stearic acidas in Example 1. Glucose payload would be approximately 75% and coatingthickness would be adjusted to give 80% release within 1-4 hours afteringestion.

Based on the above parameters, each 100 kcal of energy from glucosereleased would require 41.7 g of material.

Calculation

100 Kcal/4 Kcal per gram glucose=25.0 g glucose

25 g/0.75 payload delivery=33.3 g CRC at 100% release

3.3 g/0.80 release factor=41.7 g CRC at 80% release

The carbohydrate load and release rate can be adjusted to individualnutritional needs and product application.

Examples of different caloric deliveries using the above example arelisted below:

Product Applications for Controlled Release Carbohydrates

1. 25.0 g CRC delivers 15 g CHO and 60 kcal energy.

2. 41.7 g CRC delivers 25 g CHO and 100 kcal energy.

3. 50.0 g CRC delivers 30 g CHO and 120 kcal energy.

Nine ounces of prepared beverage is formulated to provide 22 g ofreadily absorbable, uncoated carbohydrates plus 30 g of controlledrelease carbohydrates. The CRC material is encapsulated to release asfollows:

    ______________________________________                                        Time      CHO Released Calories  Total Calories                               ______________________________________                                        Start exercise                                                                          22 g         88         88                                          60 minutes                                                                              15 g         60        148                                          120 minutes                                                                             15 g         60        208                                          ______________________________________                                    

This controlled release beverage would support two hours of strenuousexercise. If a diabetic wants to support three hours of moderateexercise, such as a round of golf, he or she would only drink 6 ouncesof beverage. This would provide:

    ______________________________________                                        Time      CHO Released Calories  Total Calories                               ______________________________________                                        Start exercise                                                                          15 g         60         60                                          60 minutes                                                                              10 g         40        100                                          120 minutes                                                                             10 g         40        140                                          ______________________________________                                    

While there will always be individual differences between people, thisproduct would generally enable the diabetic exerciser to maintain ablood sugar level between 100 and 180 mg/dl, providing they start inthis range.

By incorporating CRC into a snack bar similar to an "energy bar" or"granola bar," similar release rates could be obtained. Although theremay be a limited amount of CRC granules crushed through chewing, thebulk will be ingested intact as part of the swallowed bolus. Thequantity of readily absorbable carbohydrate released by chewing would befactored into the requirements for the calories required at the start ofexercise.

The caloric load in the above 9 oz. beverage sample could beincorporated in a single bar scored into 3 parts. For two hours ofstrenuous exercise, the subject eats the whole bar. For three hours ofmoderate exercise, the subject eats two of the three parts, withadditional carbohydrate left for future consumption. Alternatively, thecarbohydrate load might be delivered in 3 separate smaller bars.

Hypoglycemia can be a serious problem for a diabetic during thenight--usually around 3 a.m. A bedtime beverage which is taken 1/2 hourbefore sleep is formulated to provide 15 g of uncoated carbohydrates fornormal absorption and 15 grams of CRC for slow release.

    ______________________________________                                        Time     CHO Released Calories  Total Calories                                ______________________________________                                        Start sleep                                                                            15 g         60         60                                           60 minutes                                                                             5 g          20         80                                           120 minutes                                                                            5 g          20        100                                           180 minutes                                                                            5 g          20        120                                           ______________________________________                                    

This will prevent a significant fall in blood glucose during the nightfor those who have exercised vigorously during the day and are at riskof hypoglycemia for up to 30 hours after the exercise. If the bloodsugar is well controlled, the overnight blood sugar will remain withinthe acceptable range of 70-140 mg/dl. Individual variations exist andrelease curves and levels would be adjusted based on individual medicalneeds.

The product made with CRC may contain other nutrients, e.g., fiber,vitamins, and minerals to provide additional nutritional benefits.

EXAMPLE 7

Artificially sweetened powdered soft drink with 42 grams coated glucosein 8 oz of beverage.

    ______________________________________                                        Coated glucose from Example 1                                                                      42.00  g*                                                Guar gum             .40           (.10-.60)                                  Aspartame            .04           (.02-.10)                                  Citric acid          .30           (.10-.60)                                  Trisodium citrate    .26           (.15-.40)                                  Dried citrus flavor  .24           (.05-4.0)                                  Red #40              .01           (.005-.15)                                 Polysorbate          .01           (.005-.03)                                                      43.26  g                                                 ______________________________________                                         *100 kcal from glucose  25 grams glucose                                 

Add powder to 8 fl. oz. of cold water and shake or stir thoroughly anddrink.

Using the above example, uncoated sugars such as fructose, glucose orsucrose could be added to deliver a portion (10-50%) of the caloricrequirements and the level of coated glucose decreased correspondingly.

EXAMPLE 8

    ______________________________________                                        Coated glucose of Example 1                                                                        21.00  g*                                                Fine Granular Glucose                                                                              22.00         (5.0-50.)                                  Guar Gum             .40           (.10-.60)                                  Aspartame            .04           (.02-.10)                                  Citric acid          .30           (.10-.60)                                  Trisodium citrate    .26           (.15-.40)                                  Dried citrus flavor  .24           (.05-4.0)                                  Red #40              .01           (.005-.15)                                 Polysorbate          .01           (.005-0.3)                                                      44.26  g                                                 ______________________________________                                    

Formula delivers 12.6 g of carbohydrate from CRC and 22 g ofcarbohydrate from glucose.

EXAMPLE 9

    ______________________________________                                        Instant chocolate pudding                                                     ______________________________________                                        Coated fructose of Example 5                                                                      42.00  g                                                  Pregel. corn starch 18.35         (12-24)                                     Monopotassium phosphate                                                                           1.80          (1.4-2.2)                                   Tetrapotassium pyrophosphate                                                                      1.80          (1.4-2.2)                                   Mono and diglycerides                                                                             .70           (.4-1.0)                                    Cocoa powder        12.00         (8.0-16.0)                                  Aspartame           .28           (.2-.4)                                     Vanilla flavor      .07           (.01-1.4)                                                       77.00  g                                                  ______________________________________                                    

Recipe:

Pour mix into bowl. Add 2 cups cold skim milk and blend for 2-3 minuteswith beater. Pour into serving cups. Chill. Makes four 1/2 cup servings.

EXAMPLE 10

    ______________________________________                                        Snack Bar                                                                     ______________________________________                                        CRC Example 1 25.00     g        (5.0-50.)                                    Glucose       7.00               (4.0-10.)                                    Granola cereal                                                                              8.75               (4.0-10.)                                    Vegetable     2.00               (1.0-4.0)                                    Glycerine     1.50               (0.5-3.0)                                    Water         1.00               (0.5-3.0)                                    Sweet whey    1.00               (0.2-2.0)                                    Lecithin      .15                (0.5-.30)                                    Cinnamon      .15                (0.5-.30)                                    Flavoring     .10                (.02-.20)                                                  46.65     g                                                     ______________________________________                                    

Formula delivers 15 g carbohydrate from CRC and 15 g untreatedcarbohydrates from glucose and the granola cereal blend (rolled oats,wheat, glucose syrup).

EXAMPLE 11

    ______________________________________                                        Dark Chocolate Bar                                                            ______________________________________                                        CRC (Ethyl cellulose coating                                                                    25.00    g       (5-40)                                     15 g carbohydrate)                                                            Sucrose           25.00            (15-35)                                    Chocolate liquor  28.20            (10-35)                                    Cocoa butter      21.00            (10-35)                                    Lecithin          .50              (0.2-1.0)                                  Natural Flavor    .30              (0.1-0.6)                                                    100.00   g                                                  ______________________________________                                    

Formula delivers 15 g carbohydrate from CRC and 33 g carbohydrate fromsucrose and chocolate liquor.

While the invention has been described with reference to a preferredembodiment, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include all embodiments and equivalents falling within the scope ofthe appended claims.

Various features of the invention are set forth in the following claims.

What is claimed:
 1. An edible ingredient for use in foods selected fromthe group consisting of beverages, food bars, candy bars, candy, desertmixes, puddings and yogurts, said ingredient comprising:a) a core havinga metabolizable carbohydrate throughout; b) said core having a timedelay release coating for releasing said metabolizable carbohydratesubstantially only into the digestive tract of the body; c) the size ofsaid coated core being approximately about 30-about 1,000 μm, saidcoating being evenly distributed on said core; and d) whereby saidcoated core is shelf stable.
 2. The ingredient of claim 1 wherein saidcoated core has a size of from 75-500 μm.
 3. The ingredient of claim 1wherein said core is selected from the group consisting of sucrose,glucose, lactose, dextrins, pregelatinized starches, fructose, maltose,monosaccharides, disaccharides, oligosaccharides, and polysaccharides.4. An edible ingredient for use in beverages, said ingredientcomprising:a) a core having a metabolizable carbohydrate throughout; b)said core having a time delay release coating said coating providing forthe release of substantially all said metabolizable carbohydrate intothe digestive system for one-half to four hours after ingestion; c) thesize of said coated core being approximately about 30-about 1,000 μm,said coating being evenly distributed on said core; and d) whereby saidcoated core is shelf stable.